Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00684242
Status:
TERMINATED
Last Update Posted:
2013-01-28
First Post:
2008-05-22
Brief Title:
Lenalidomide Revlimid for the Treatment of Refractory Cancer Pain
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Pilot Clinical Trial of Lenalidomide Revlimid for the Treatment of Refractory Cancer Pain
Status:
TERMINATED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if lenalidomide can help to treat uncontrolled pain caused by advanced cancer
Primary Objectives
1 Determine efficacy of Lenalidomide for the treatment of refractory cancer pain as measured by the change on Edmonton symptom assessment scale ESAS
Secondary Objectives
1 To determine the effect of Lenalidomide on fatigue sleep depressed mood nausea and appetiteanorexia
2 Determine changes in serum levels of inflammatory cytokines IL-1beta IL-6 TNF-alpha interferonIFN-alpha and IFN-gamma and C-reactive protein before and after treatment with Lenalidomide
3 Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
4 Effect of Lenalidomide on the expression of costimulatory receptors CD80 CD86 and CD40 on myeloid and plasmacytoid dendritic cells
5 Safety type frequency severity and relationship of adverse events to study treatment
Primary Objectives
1 Determine efficacy of Lenalidomide for the treatment of refractory cancer pain as measured by the change on Edmonton symptom assessment scale ESAS
Secondary Objectives
1 To determine the effect of Lenalidomide on fatigue sleep depressed mood nausea and appetiteanorexia
2 Determine changes in serum levels of inflammatory cytokines IL-1beta IL-6 TNF-alpha interferonIFN-alpha and IFN-gamma and C-reactive protein before and after treatment with Lenalidomide
3 Effect of Lenalidomide on T-cell subsets especially T-regulatory cells
4 Effect of Lenalidomide on the expression of costimulatory receptors CD80 CD86 and CD40 on myeloid and plasmacytoid dendritic cells
5 Safety type frequency severity and relationship of adverse events to study treatment
Detailed Description:
The Study Drug
Lenalidomide is designed to change the bodys immune system It may also interfere with the development of tiny blood vessels that help support tumor growth Therefore in theory it may decrease or prevent the growth of cancer cells The drug is also designed to decrease the level of certain proteins in the blood called cytokines which may result in decreased pain
Study Drug Administration
If you are found to be eligible to take part in this study you will take lenalidomide capsules each morning with or without food Take lenalidomide capsules whole with a 4-ounce 12 cup glass of water at the same time each day Do not break chew or open the capsules If you miss a dose of lenalidomide take it as soon as you remember on the same day If you miss taking your dose for the entire day take your regular dose the next scheduled day do NOT take double your regular dose to make up for the missed dose
If you take too much lenalidomide call your study doctor or health care provider or poison control center right away
You will also be allowed to take strong pain killers such as morphine as prescribed by your study doctor for pain If you need more than 3 doses of these pain killers in a 24-hour period you should call your study doctor
Study Visits
You will visit the clinic throughout the study At each visit you will be asked to return any unused study drug and empty bottles to the clinic and you will be asked about any side effects you may be experiencing The last study visit will be on Day 43 or Day 57 depending on the side effects you may experience The following tests and procedures will be performed
On Day 8
Blood about 1 tablespoon will be drawn for routine tests and women who are able to have children will have a blood pregnancy test
Day 15
Blood about 1 tablespoon will be drawn for routine tests Women who are able to have children will have a blood 1-2 teaspoons pregnancy test You will complete 5 questionnaires about the pain the pain symptoms and any side effects you may be having The questionnaires will take about 30 to 40 minutes to complete Women who are able to have children will have a blood pregnancy test
Day 22
Blood about 1 tablespoon will be drawn for routine tests Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 29
You will complete the same questionnaires as on Day 15 Women who are able to have children will have a blood pregnancy test and will be counseled about pregnancy precautions and risks Blood about 1 tablespoon will be drawn for routine tests Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 36
Blood about 1 tablespoon will be drawn for routine tests
Day 43
Blood about 1 tablespoon will be drawn for routine tests You will complete the same questionnaires as on Day 15 If this is your last visit you will have an ECG Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 57 if necessary
You will complete the same questionnaires as on Day 15 Blood about 1 tablespoon will be drawn for routine tests You will complete the same questionnaires as on Day 15 If this is your last visit you will have an ECG Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 71 if necessary
If you stopped taking the drug on Day 57 a blood 1-2 teaspoons pregnancy test will be done
Length of Study
You may take lenalidomide for up to 57 days You will be taken off study if the disease gets worse or if intolerable side effects occur
If you are a female who is able to have children and you do take lenalidomide for all 57 days you will be required to have a blood 1-2 teaspoons pregnancy test 28 days after your last dose of lenalidomide
The routine blood draws on Days 8 22 and 36 may done at your home by a study nurse local doctors office or at M D Anderson
All patients who were on lenalidomide and then stopped taking it will be checked every 3 to 5 weeks for a period of 1 year During the follow-up visits certain tests and procedures will be performed These include a symptom questionnaire blood draw for routine tests a check of your side effects and pregnancy testing for women who are still able to become pregnant These are the same tests that were done while you were on the study
Daily Drug Diary and Questionnaire
Starting on Day 1 until the end of the study you will complete a questionnaire once daily about any symptoms and pain you may be experiencing It will take about 5 minutes to complete each time You will also be provided with a drug diary to write down when and how often you take pain medication You should bring your completed diary to each study visit so it can be reviewed by the research nurse
Phone Call Follow-up
You will be contacted by telephone at home to be asked questions about your symptoms and any side effects you may have experienced You will be called on Day 8 plus or minus 3 days Day 22 plus or minus 3 days and Day 36 plus or minus 3 days The phone calls will last about 10-15 minutes each time
End-of-Study Visit
You will come to the clinic 28 days after your last dose of lenalidomide for a follow-up visit You will be checked for side effects and women who are able to have children must have a negative blood 1-2 teaspoons pregnancy test
This is an investigational study Lenalidomide is approved by FDA for the treatment of myelodysplastic syndrome MDS and in combination with dexamethasone for patients with multiple myeloma MM Lenalidomide is not FDA approved for pain relief Its use in this study is investigational If you experience intolerable pain after you stop receiving the study drug you will be allowed to start receiving lenalidomide off study You will be monitored for side effects for every 2-3 weeks while you are on this medication for a period of 1 year Up to 15 patients will take part in this study All will be enrolled at M D Anderson
Lenalidomide is designed to change the bodys immune system It may also interfere with the development of tiny blood vessels that help support tumor growth Therefore in theory it may decrease or prevent the growth of cancer cells The drug is also designed to decrease the level of certain proteins in the blood called cytokines which may result in decreased pain
Study Drug Administration
If you are found to be eligible to take part in this study you will take lenalidomide capsules each morning with or without food Take lenalidomide capsules whole with a 4-ounce 12 cup glass of water at the same time each day Do not break chew or open the capsules If you miss a dose of lenalidomide take it as soon as you remember on the same day If you miss taking your dose for the entire day take your regular dose the next scheduled day do NOT take double your regular dose to make up for the missed dose
If you take too much lenalidomide call your study doctor or health care provider or poison control center right away
You will also be allowed to take strong pain killers such as morphine as prescribed by your study doctor for pain If you need more than 3 doses of these pain killers in a 24-hour period you should call your study doctor
Study Visits
You will visit the clinic throughout the study At each visit you will be asked to return any unused study drug and empty bottles to the clinic and you will be asked about any side effects you may be experiencing The last study visit will be on Day 43 or Day 57 depending on the side effects you may experience The following tests and procedures will be performed
On Day 8
Blood about 1 tablespoon will be drawn for routine tests and women who are able to have children will have a blood pregnancy test
Day 15
Blood about 1 tablespoon will be drawn for routine tests Women who are able to have children will have a blood 1-2 teaspoons pregnancy test You will complete 5 questionnaires about the pain the pain symptoms and any side effects you may be having The questionnaires will take about 30 to 40 minutes to complete Women who are able to have children will have a blood pregnancy test
Day 22
Blood about 1 tablespoon will be drawn for routine tests Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 29
You will complete the same questionnaires as on Day 15 Women who are able to have children will have a blood pregnancy test and will be counseled about pregnancy precautions and risks Blood about 1 tablespoon will be drawn for routine tests Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 36
Blood about 1 tablespoon will be drawn for routine tests
Day 43
Blood about 1 tablespoon will be drawn for routine tests You will complete the same questionnaires as on Day 15 If this is your last visit you will have an ECG Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 57 if necessary
You will complete the same questionnaires as on Day 15 Blood about 1 tablespoon will be drawn for routine tests You will complete the same questionnaires as on Day 15 If this is your last visit you will have an ECG Women who are able to have children will have a blood 1-2 teaspoons pregnancy test
Day 71 if necessary
If you stopped taking the drug on Day 57 a blood 1-2 teaspoons pregnancy test will be done
Length of Study
You may take lenalidomide for up to 57 days You will be taken off study if the disease gets worse or if intolerable side effects occur
If you are a female who is able to have children and you do take lenalidomide for all 57 days you will be required to have a blood 1-2 teaspoons pregnancy test 28 days after your last dose of lenalidomide
The routine blood draws on Days 8 22 and 36 may done at your home by a study nurse local doctors office or at M D Anderson
All patients who were on lenalidomide and then stopped taking it will be checked every 3 to 5 weeks for a period of 1 year During the follow-up visits certain tests and procedures will be performed These include a symptom questionnaire blood draw for routine tests a check of your side effects and pregnancy testing for women who are still able to become pregnant These are the same tests that were done while you were on the study
Daily Drug Diary and Questionnaire
Starting on Day 1 until the end of the study you will complete a questionnaire once daily about any symptoms and pain you may be experiencing It will take about 5 minutes to complete each time You will also be provided with a drug diary to write down when and how often you take pain medication You should bring your completed diary to each study visit so it can be reviewed by the research nurse
Phone Call Follow-up
You will be contacted by telephone at home to be asked questions about your symptoms and any side effects you may have experienced You will be called on Day 8 plus or minus 3 days Day 22 plus or minus 3 days and Day 36 plus or minus 3 days The phone calls will last about 10-15 minutes each time
End-of-Study Visit
You will come to the clinic 28 days after your last dose of lenalidomide for a follow-up visit You will be checked for side effects and women who are able to have children must have a negative blood 1-2 teaspoons pregnancy test
This is an investigational study Lenalidomide is approved by FDA for the treatment of myelodysplastic syndrome MDS and in combination with dexamethasone for patients with multiple myeloma MM Lenalidomide is not FDA approved for pain relief Its use in this study is investigational If you experience intolerable pain after you stop receiving the study drug you will be allowed to start receiving lenalidomide off study You will be monitored for side effects for every 2-3 weeks while you are on this medication for a period of 1 year Up to 15 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None